Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803
Summary
The purpose of this study is to find the number of natural killer (NK) cells from non-HLA matched donors that can be safely infused into patients with cancer. NK cells are a form of lymphocytes that defend against cancer cells. NK cells in cancer patients do not work well to fight cancer. In this study, the NK cells are being donated by healthy individuals without cancer who are not "matched" by human leukocyte antigen (HLA) genes to patients. After receiving these NK cells, patients may also be given a drug called ALT803. ALT803 is a protein that keeps NK cells alive, helps them grow in number and supports their cancer-fighting characteristics. HLA-unmatched NK cell infusion is investigational (experimental) because the process has not approved by the Food and Drug Administration (FDA).
Timeline
- Start
- 2018-05-22
- Primary completion
- 2021-06-01
- Completion
- 2023-02-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | N-803 | Protein / enzyme biologic | 6 ug/kg | — |
| Subject | natural killer (NK) cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | natural killer (NK) cells | Cell therapy | 1e+07 cells/kg | — |
| Subject | natural killer (NK) cells | Cell therapy | 2.5e+07 cells/kg | — |
| Subject | natural killer (NK) cells | Cell therapy | 5e+07 cells/kg | — |